Breast cup

ABSTRACT

A breast cup for obtaining breast milk is provided that has flexible regions integrally molded with the rest of the inner part of the breast cup which provide massaging or stimulating action to selected areas of the breast and nipple.

RELATED APPLICATIONS

This application claims priority in co-pending U.S. Provisional Application No. 60/600,226, filed on Aug. 10, 2004, the disclosure of which is incorporated herein by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to apparatus and methods for obtaining breast milk. More particularly, the present invention relates to a breast cup that applies a massaging or stimulating action a breast and nipple to express breast milk.

2. Description of the Related Art

Breast pump systems for obtaining breast milk, both manually and automatically, are known in the art. In U.S. application Ser. No. 10/220,034 to Ytteborg (publication no. 2003/0153869 A1), a breast cup is disclosed having inner and outer parts joined together. The inner part has a number of openings formed therein and has flexible membranes covering the openings. The flexible membranes are in communication with a pressure source through tubes formed in the outer part. The flexible membranes provide a stimulating, massaging action upon selected areas of the breast. A first set of the flexible membranes is positioned over the nipple of the woman and a second set of the flexible membranes is positioned about the base of the nipple.

The Ytteborg breast cup suffers from the drawback of requiring separate manufacturing of the inner part and the flexible membranes, and then a secondary process of attaching the flexible membranes over the openings. This is a more costly and time-consuming process. Additionally, the accuracy of the position of the flexible membrane over the opening, as well as the seal between the flexible membrane and the inner part must be ensured in order for the Ytteborg breast cup to properly function. Over time and usage, this configuration may also become susceptible to separation and leakage.

Accordingly, there is a need for a breast cup, which provides massaging and stimulating action to selected areas of the breast and nipple without the above-described drawbacks.

SUMMARY OF THE INVENTION

It is an object of the present invention to provide a breast cup with massaging and stimulating action to selected areas of the breast and nipple.

It is another object of the present invention to provide such a breast cup with material having varying properties.

It is yet another object of the present invention to facilitate the manufacture of such a breast cup.

These and other objects and advantages of the present invention are provided by a breast cup having flexible regions that are integrally formed with the rest of the inner part of the breast cup. The flexible regions can be made from the same material but a different grade of the material, as the rest of the inner part of the breast cup. The grade of material used for the flexible regions has more flexibility than the grade of material used for the rest of the inner part. The flexible regions can also have less of a thickness to facilitate flexure of the region. The breast cup can also use a combination of varying thickness and varying grades to facilitate flexure of the flexible regions while maintaining the rigidity of the rest of the inner part.

In one aspect, a breast cup is provided comprising an outer part, an inner part and a pressure conduit. The outer part is substantially shaped as a truncated cone with a conical portion and a substantially cylindrical portion downstream of the conical portion. The inner part has a first flexible region, a rigid remainder and a shape that substantially corresponds to the outer part. The pressure conduit is in communication with a pressure source. A first cavity is formed between the first flexible region and the outer part when the outer part is connected to the inner part. The first cavity is in communication with the pressure conduit to provide a massaging pressure through flexure of the first flexible region. The first flexible region overlies the conical portion of the outer part, and the first flexible region and the rigid remainder are integrally formed during a molding process of the breast cup.

In another aspect, a method of making a breast cup is provided comprising molding an outer part substantially shaped as a truncated cone with a conical portion, a substantially cylindrical portion downstream of the conical portion and a pressure conduit; and molding an inner part having a first flexible region, a rigid remainder and a shape that substantially corresponds to the outer part by integrally forming the first flexible region and the rigid remainder during the molding. The first flexible region overlies the conical portion of the outer part when the outer part is connected with the inner part. A first cavity is formed between the outer and inner parts when connected that is in communication with the pressure conduit.

The first flexible region and the rigid remainder can be made from a single material having different grades of hardness. The single material may be injection molded to form the inner part via a single shot process. The single material can be injection molded to form the inner part via a double shot process. The single material can be taken from the group consisting essentially of silicone, thermoplastic elastomers, or elastomeric rubbers.

The inner part may further comprise a second flexible region that is integrally formed with the first flexible region and the rigid remainder during the molding process of the breast cup. A second cavity can be formed between the second flexible region and the outer part when the outer part is connected to the inner part. The second cavity is in communication with the pressure conduit to provide a massaging pressure through flexure of the second flexible region. The second flexible region overlies the cylindrical portion of the outer part. The second flexible region may have a wave-like shape.

The breast cup can further comprise sealing rings that provide for a sealing engagement of the outer part with the inner part and fluid isolation of the first and second cavities. The second flexible region may be divided into a plurality of second regions by a portion of the rigid remainder. The first flexible region can be divided into a plurality of first regions by a portion of the rigid remainder. The first flexible region may have a wave-like shape. The outer and inner parts can be selectively removable.

BRIEF DESCRIPTION OF THE DRAWINGS

Other and further objects, advantages and features of the present invention will be understood by reference to the following:

FIG. 1 is an exploded plan view of a prior art breast cup;

FIG. 2 is a perspective view of the inner part of the prior art breast cup of FIG. 1 without the flexible membranes covering the openings;

FIG. 3 is a perspective view of the inner part of the prior art breast cup of FIG. 1 with the flexible membranes covering the openings;

FIG. 4 is a cross-sectional view of the prior art breast cup of FIG. 1;

FIG. 5 is an exploded plan view of a breast cup of the present invention;

FIG. 6 is a perspective view of the inner part of the breast cup of FIG. 5;

FIG. 7 is a cross-sectional view of the breast cup of FIG. 5

FIG. 8 is an exploded plan view of a second embodiment of a breast cup of the present invention;

FIG. 9 is a perspective view of the inner part of the breast cup of FIG. 8;

FIG. 10 is an exploded plan view of a third embodiment of a breast cup of the present invention;

FIG. 11 is a perspective view of the inner part of the breast cup of FIG. 10;

FIG. 12 is an exploded plan view of a fourth embodiment of a breast cup of the present invention; and

FIG. 13 is a cross-sectional view of the inner part of the breast cup of FIG. 12.

DESCRIPTION OF THE INVENTION

FIGS. 1 through 4 show the prior art breast cup of U.S. application Ser. No. 10/220,034 to Ytteborg with flexible membranes covering the openings of the inner part of the breast cup. The flexible membranes of the prior art breast cup are made from a thermoplastic elastomer. The inner and outer parts of the prior art breast cup are made from plastic such as polypropylene. The inner and outer parts and the flexible membranes of the prior art breast cup must be compatible materials that allow for welding or gluing them together. As described above, this prior art breast cup suffers from drawbacks that are remedied by the breast cup of the present invention.

Referring to FIGS. 5 through 7, there is shown a preferred embodiment of the breast cup of the present invention generally represented by reference numeral 100. Breast cup 100 has an outer part 110 and an inner part 120. In the embodiment shown, outer part 110 is the prior art outer part shown in FIGS. 1 through 4, which has pressure conduits 115, and is substantially shaped as a truncated cone with a conical portion and a substantially cylindrical portion downstream of the conical portion. However, the present invention contemplates the use of other structures for outer part 110, and alternative pressure supplying structures and methods, such as, for example, pressure conduits formed in the walls of the outer part.

Inner part 120 has a first flexible region 130 and a second flexible region 140. The first and second flexible regions 130 and 140 are integrally formed with inner part 120 during the molding process. In the preferred embodiment, the first and second flexible regions 130 and 140 are made from a flexible material, while the remainder of the inner part 120 is made from the same material but a different grade, i.e., having different properties, which is more rigid.

Use of the same material but different grades having flexibility or rigidity, allows the inner part 120 to provide for massaging or stimulating action on selected areas of the breast and nipple (at the flexible regions 130 and 140) while maintaining the strength and integrity of the inner part, as well as facilitating the manufacturing process. The different grades of the same material can be injection molded using single shot or double shot processes. Alternative molding techniques and methods can also be used to integrally mold flexible regions 130 and 140 with inner part 120.

The material used can be capable of flexure depending upon the type and grade used. Such materials include, but are not limited to, silicone, thermoplastic elastomers, or other elastomeric rubber materials, whose durometers (hardness) can be varied.

Alternatively, different materials can be used for first and second flexible regions 130 and 140, in contrast to the rest of the inner part 120. The different materials should be compatible so that the first and second flexible regions 130 and 140 can be integrally formed or molded with the inner part 120, such as, for example, single shot or double shot molding, in order to avoid the need for gluing or welding.

The flexible regions 130 and 140 have a wave-like shape or ridges 135 and 145, respectively. However, the present invention contemplates the use of other shapes for the surface of flexible regions 130 and 140.

When the outer part 110 is connected, removably connected and/or attached to the inner part 120, as indicated by arrow 150, cavities 160 are formed between the flexible regions 130 and 140 and the outer part 110. The cavities 160 are in communication with the pressure conduits 115 to provide a positive massaging pressure through flexure of the flexible regions 130 and 140, similar to the prior art breast cup of FIGS. 1 through 4. However, due to the use of the same material but with different properties and/or the simpler manufacturing process, the breast cup 100 of the present invention has distinct advantages of the breast cup of FIGS. 1 through 4.

The inner part 120 also has sealing rings 180 about the circumference of various areas of the inner part. The sealing rings 180 correspond in size and shape to inner areas of the outer part 110 to provide for a sealing engagement of the outer part with the inner part 120, and to assist in sealing off the cavities 160. In the preferred embodiment, first and second flexible regions 130 and 140 are each separated into two areas or regions of the inner part 120 to form a non-flexible or less flexible region 190 therebetween. However, the present invention contemplates the use of any number of areas for each of the first and second flexible regions 130 and 140. The present invention further contemplates the use of other numbers of flexible regions circumferentially disposed along the inner part 120, as well as disposed in different positions and/or configurations.

The breast cup 100 has a vacuum tube 118 that provides for application of a vacuum or negative pressure to the nipple through the inner chamber 195 of the breast cup, as shown in FIG. 7. The vacuum is transmitted to the central portion of the nipple via the inner chamber 195. However, alternative structures and methods can also be used to apply a vacuum or negative pressure to the nipple.

The inner part 120 can be permanently connected or attached to the outer part 110 via adhesive, welding or other attachment methods. Alternatively, the inner part 120 can be selectively removable from the outer part 110 to facilitate cleaning. Various attachment structures and methods can be utilized to provide for the selective engagement of the outer and inner parts 110 and 120.

Referring to FIGS. 8 and 9, there is shown a second embodiment of the breast cup of the present invention generally represented by reference numeral 200. Breast cup 200 has an outer part 210 and an inner part 220. In the embodiment shown, outer part 210 is the prior art outer part shown in FIGS. 1 through 4, which has pressure conduits 215. However, the present invention contemplates the use of other structures for outer part 210, and alternative pressure supplying structures and methods, such as, for example, pressure conduits formed in the walls of the outer part.

Similar to inner part 120 of the preferred embodiment of FIGS. 5 through 7, inner part 220 has a first flexible region 230 and a second flexible region 240. However, flexible regions 230 and 240 are formed entirely about the circumference of the inner part. The first and second flexible regions 230 and 240 are integrally formed with inner part 220 during the molding process. First and second flexible regions 230 and 240 are made from a flexible material, while the remainder of the inner part 220 is made from the same material but a different grade, i.e., having different properties, which is more rigid.

Use of the same material but different grades having flexibility or rigidity, allows the inner part 220 to provide for massaging or stimulating action on selected areas of the breast and nipple (at the flexible regions 230 and 240) while maintaining the strength and integrity of the inner part, as well as facilitating the manufacturing process. The different grades of the same material can be injection molded using single shot or double shot processes. Alternative molding techniques and methods can also be used to integrally mold flexible regions 230 and 240 with inner part 220.

The material used can be capable of flexure depending upon the type and grade used. Such materials include, but are not limited to, silicone, thermoplastic elastomers, or other elastomeric rubber materials, whose durometers (hardness) can be varied.

Alternatively, different materials can be used for first and second flexible regions 230 and 240, in contrast to the rest of the inner part 220. The different materials should be compatible so that the first and second flexible regions 230 and 240 can be integrally formed or molded with the inner part 220, such as, for example, single shot or double shot molding, in order to avoid the need for gluing or welding.

The flexible regions 230 and 240 have a wave-like shape or ridges 235 and 245, respectively. However, the present invention contemplates the use of other shapes for the surface of flexible regions 230 and 240.

When the outer part 210 is connected, removably connected and/or attached to the inner part 220, as indicated by arrow 250, cavities are formed between the flexible regions 230 and 240 and the outer part 210. The cavities are in communication with the pressure conduits 215 to provide a positive massaging pressure through flexure of the flexible regions 230 and 240, similar to the prior art breast cup of FIGS. 1 through 4. However, due to the use of the same material but with different properties and/or the simpler manufacturing process, the breast cup 200 of the present invention has distinct advantages of the breast cup of FIGS. 1 through 4.

The inner part 220 also has sealing rings 280 about the circumference of various areas of the inner part. The sealing rings 280 correspond in size and shape to inner areas of the outer part 210 to provide for a sealing engagement of the outer part with the inner part 220, and to assist in sealing off the cavities. The sealing rings 280 are especially significant in this embodiment due to the flexible regions 230 and 240 circumnavigating the entire inner part 210.

The breast cup 200 has a vacuum tube 218 that provides for application of a vacuum or negative pressure to the nipple through the inner chamber of the breast cup. The vacuum is transmitted to the central portion of the nipple via the inner chamber. However, alternative structures and methods can also be used to apply a vacuum or negative pressure to the nipple.

The inner part 220 can be permanently connected or attached to the outer part 210 via adhesive, welding or other attachment methods. Alternatively, the inner part 220 can be selectively removable from the outer part 210 to facilitate cleaning. Various attachment structures and methods can be utilized to provide for the selective engagement of the outer and inner parts 210 and 220.

Referring to FIGS. 10 and 11, there is shown a third embodiment of the breast cup of the present invention generally represented by reference numeral 300. Breast cup 300 has an outer part 310 and an inner part 320. In the embodiment shown, outer part 310 is the prior art outer part shown in FIGS. 1 through 4, which has pressure conduits 315. However, the present invention contemplates the use of other structures for outer part 310, and alternative pressure supplying structures and methods, such as, for example, pressure conduits formed in the walls of the outer part.

Inner part 320 has a first flexible region 330 and a second flexible region 340. The boundaries of the first and second regions 330 and 340 are represented by reference numerals 331 and 341, respectively. The first and second flexible regions 330 and 340 are integrally formed with inner part 320, preferably during the molding process. In the preferred embodiment, the first and second flexible regions 330 and 340 are made from a flexible material, while the remainder of the inner part 320 is made from the same material but a different grade, i.e., having different properties, which is more rigid.

Use of the same material but different grades having flexibility or rigidity, allows the inner part 320 to provide for massaging or stimulating action on selected areas of the breast and nipple (at the flexible regions 330 and 340) while maintaining the strength and integrity of the inner part, as well as facilitating the manufacturing process. The different grades of the same material can be injection molded using single shot or double shot processes. Alternative molding techniques and methods can also be used to integrally mold flexible regions 330 and 340 with inner part 320.

The material used can be capable of flexure depending upon the type and grade used. Such materials include, but are not limited to, silicone, thermoplastic elastomers, or other elastomeric rubber materials, whose durometers (hardness) can be varied.

Alternatively, different materials can be used for first and second flexible regions 330 and 340, in contrast to the rest of the inner part 320. The different materials should be compatible so that the first and second flexible regions 330 and 340 can be integrally formed or molded with the inner part 320, such as, for example, single shot or double shot molding, in order to avoid the need for gluing or welding.

Unlike the flexible regions 130 and 140 of the first embodiment which have a wave-like shape, the flexible regions 330 and 340 of breast cup have a flat or substantially flat surface. However, the present invention contemplates the use of other shapes for the surface of flexible regions 330 and 340.

When the outer part 310 is connected, removably connected and/or attached to the inner part 320, as indicated by arrow 350, cavities are formed between the flexible regions 330 and 340 and the outer part 310. The cavities are in communication with the pressure conduits 315 to provide a positive massaging pressure through flexure of the flexible regions 330 and 340, similar to the prior art breast cup of FIGS. 1 through 4. However, due to the use of the same material but with different properties and/or the simpler manufacturing process, the breast cup 300 of the present invention has distinct advantages of the breast cup of FIGS. 1 through 4.

The inner part 320 also has sealing rings 380 about the circumference of various areas of the inner part. The sealing rings 380 correspond in size and shape to inner areas of the outer part 310 to provide for a sealing engagement of the outer part with the inner part 320, and to assist in sealing off the cavities. First and second flexible regions 330 and 340 are each separated into two areas or regions of the inner part 320 to form a non-flexible or less flexible region 390 therebetween. However, the present invention contemplates the use of any number of areas for each of the first and second flexible regions 330 and 340. The present invention further contemplates the use of other numbers of flexible regions circumferentially disposed along the inner part 320, as well as disposed in different positions and/or configurations.

The breast cup 300 has a vacuum tube 318 that provides for application of a vacuum or negative pressure to the nipple through the inner chamber of the breast cup. The vacuum is transmitted to the central portion of the nipple via the inner chamber. However, alternative structures and methods can also be used to apply a vacuum or negative pressure to the nipple.

The inner part 320 can be permanently connected or attached to the outer part 310 via adhesive, welding or other attachment methods. Alternatively, the inner part 320 can be selectively removable from the outer part 310 to facilitate cleaning. Various attachment structures and methods can be utilized to provide for the selective engagement of the outer and inner parts 310 and 320.

Referring to FIGS. 12 and 13, there is shown a fourth embodiment of the breast cup of the present invention generally represented by reference numeral 400. Breast cup 400 has an outer part 410 and an inner part 420. In the embodiment shown, outer part 410 is the prior art outer part shown in FIGS. 1 through 4, which has pressure conduits 415. However, the present invention contemplates the use of other structures for outer part 410, and alternative pressure supplying structures and methods, such as, for example, pressure conduits formed in the walls of the outer part.

Inner part 420 has a first flexible region 430 and a second flexible region 440. The first and second flexible regions 430 and 440 are integrally formed with inner part 420 during the molding process. First and second flexible regions 430 and 440 are thinner than the rest of the inner part 420 so that the flexible regions can provide the massaging or stimulating action to the selected areas of the breast and nipple, while maintaining the rigidity or reduced flexibility of the rest of the inner part of the breast cup 400.

The breast cup 400 can use the same grade of material or can use different grades of material having the desired flexibility or rigidity, to facilitate the massaging or stimulating action on the selected areas of the breast and nipple (at the flexible regions 430 and 440) while maintaining the strength and integrity of the inner part, as well as facilitating the manufacturing process. Where different grades of the same material are used, they can be injection molded using single shot or double shot processes. Alternative molding techniques and methods can also be used to integrally mold flexible regions 430 and 440 with inner part 420.

Alternatively, different materials can be used for first and second flexible regions 430 and 440, in contrast to the rest of the inner part 420. The different materials should be compatible so that the first and second flexible regions 430 and 440 can be integrally formed or molded with the inner part 420, such as, for example, single shot or double shot molding, in order to avoid the need for gluing or welding. The material used can be capable of flexure depending upon the type and grade used. Such materials include, but are not limited to, silicone, thermoplastic elastomers, or other elastomeric rubber materials, whose durometers (hardness) can be varied. The inner part 420 can be polypropylene, polyethylene, ABS, polycarbonate or another appropriate hard plastic material. The flexible regions 430 and 440 could be a thermoplastic elastomers or other elastomeric rubber materials that would chemically bond with the material(s) chosen for inner part 420.

The flexible regions 430 and 440 have a wave-like shape or ridges 435 and 445, respectively. However, the present invention contemplates the use of other shapes for the surface of flexible regions 430 and 440, as well as a flat or substantially flat surface.

When the outer part 410 is connected, removably connected and/or attached to the inner part 420, as indicated by arrow 450, cavities are formed between the flexible regions 430 and 440 and the outer part 410. The cavities are in communication with the pressure conduits 415 to provide a positive massaging pressure through flexure of the flexible regions 430 and 440, similar to the prior art breast cup of FIGS. 1 through 4. However, due to the use of the reduced thickness and/or the same material but with different properties and/or the simpler manufacturing process, the breast cup 100 of the present invention has distinct advantages of the breast cup of FIGS. 1 through 4.

The inner part 420 also has sealing rings 480 about the circumference of various areas of the inner part. The sealing rings 480 correspond in size and shape to inner areas of the outer part 410 to provide for a sealing engagement of the outer part with the inner part 420, and to assist in sealing off the cavities. In the preferred embodiment, first and second flexible regions 430 and 440 are each separated into two areas or regions of the inner part 420 to form a non-flexible or less flexible region 490 therebetween. However, the present invention contemplates the use of any number of areas for each of the first and second flexible regions 430 and 440. The present invention further contemplates the use of other numbers of flexible regions circumferentially disposed along the inner part 420, as well as disposed in different positions and/or configurations.

The difference in thickness of the thinner first and second flexible regions 430 and 440, as compared to the thicker and less flexible remaining portions of the inner part 420, are shown more clearly in FIG. 13. The inner part 420 has rigid walls 431 in the area of flexible region 430 and rigid walls 441 in the area of flexible region 440, which partially define the hood-like or funnel shape of the inner part. The sealing rings have annular sealing walls 481. The flexible regions 430 and 440 have flexible walls 432 and 442, respectively, which in this embodiment have a wave-like shape. The flexible walls 432 and 442 have a reduced thickness as compared to rigid walls 431 and 441 and sealing walls 481.

The breast cup 400 has a vacuum tube 418 that provides for application of a vacuum or negative pressure to the nipple through the inner chamber of the breast cup. The vacuum is transmitted to the central portion of the nipple via the inner chamber. However, alternative structures and methods can also be used to apply a vacuum or negative pressure to the nipple.

The inner part 420 can be permanently connected or attached to the outer part 410 via adhesive, welding or other attachment methods. Alternatively, the inner part 420 can be selectively removable from the outer part 410 to facilitate cleaning. Various attachment structures and methods can be utilized to provide for the selective engagement of the outer and inner parts 410 and 420.

The above-described embodiments of the breast cup of the present invention can be used with both automatic and manual pressure sources. The flexible regions described above, and their unique design and manufacturing process can be adapted for use with other types and shapes of breast cups.

The present invention having been thus described with particular reference to the preferred forms thereof, it will be obvious that various changes and modifications may be made therein without departing from the spirit and scope of the present invention as defined in the appended claims. 

1. A breast cup comprising: an outer part substantially shaped as a truncated cone with a conical portion and a substantially cylindrical portion downstream of the conical portion; an inner part having a first flexible region, a rigid remainder and a shape that substantially corresponds to said outer part; and a pressure conduit in communication with a pressure source, wherein a first cavity is formed between said first flexible region and said outer part when said outer part is connected to said inner part, wherein said first cavity is in communication with said pressure conduit to provide a massaging pressure through flexure of said first flexible region, wherein said first flexible region overlies said conical portion of said outer part, and wherein said first flexible region and said rigid remainder are integrally formed during a molding process of the breast cup.
 2. The breast cup of claim 1, wherein said first flexible region and said rigid remainder are made from a single material having different grades of hardness.
 3. The breast cup of claim 2, wherein said single material is injection molded to form said inner part via a single shot process.
 4. The breast cup of claim 2, wherein said single material is injection molded to form said inner part via a double shot process.
 5. The breast cup of claim 2, wherein said single material is taken from the group consisting essentially of silicone, thermoplastic elastomers, or elastomeric rubbers.
 6. The breast cup of claim 1, wherein said inner part further comprises a second flexible region that is integrally formed with said first flexible region and said rigid remainder during said molding process of the breast cup, wherein a second cavity is formed between said second flexible region and said outer part when said outer part is connected to said inner part, wherein said second cavity is in communication with said pressure conduit to provide a massaging pressure through flexure of said second flexible region, and wherein said second flexible region overlies said cylindrical portion of said outer part.
 7. The breast cup of claim 6, wherein said second flexible region has a wave-like shape.
 8. The breast cup of claim 6, further comprising sealing rings that provide for a sealing engagement of the outer part with the inner part and fluid isolation of said first and second cavities.
 9. The breast cup of claim 6, wherein said second flexible region is divided into a plurality of second regions by a portion of the rigid remainder.
 10. The breast cup of claim 1, wherein said first flexible region is divided into a plurality of first regions by a portion of the rigid remainder.
 11. The breast cup of claim 1, wherein said first flexible region has a wave-like shape.
 12. The breast cup of claim 1, wherein said outer and inner parts are selectively removable.
 13. A method of making a breast cup comprising: molding an outer part substantially shaped as a truncated cone with a conical portion, a substantially cylindrical portion downstream of the conical portion and a pressure conduit; and molding an inner part having a first flexible region, a rigid remainder and a shape that substantially corresponds to said outer part by integrally forming said first flexible region and said rigid remainder during said molding, wherein said first flexible region overlies said conical portion of said outer part when said outer part is connected with said inner part, and wherein a first cavity is formed between said outer and inner parts when connected that is in communication with said pressure conduit.
 14. The method of claim 13, wherein said first flexible region and said rigid remainder are made from a single material having different grades of hardness.
 15. The method of claim 14, wherein said single material is injection molded to form said inner part via a single shot process.
 16. The method of claim 14, wherein said single material is injection molded to form said inner part via a double shot process.
 17. The method of claim 14, wherein said single material is taken from the group consisting essentially of silicone, thermoplastic elastomers, or elastomeric rubbers.
 18. The method of claim 13, further comprising integrally forming a second flexible region with said first flexible region and said rigid remainder during said molding, wherein said second flexible region overlies said cylindrical portion of said outer part when said outer part is connected with said inner part, and wherein said first cavity is formed between said outer and inner parts when connected that is in communication with said pressure conduit.
 19. The method of claim 14, wherein said first flexible region has a wave-like shape.
 20. The method of claim 18, wherein said second flexible region has a wave-like shape. 